Reliability and Validity of the Turkish Version of the GCPS 2.0.(Graded Chronic Pain Scale 2.0) (GCPS)

July 13, 2021 updated by: Yeditepe University

Reliability and Validity of the Turkish Version of the Graded Chronic Pain Scale 2.0

This study was designed to conduct Turkish adaptation, cross-cultural adaptation, validity, and reliability study of Graded Chronic Pain Scale 2.0 in order to use it for Turkish people with Chronic Pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The GCPS 2.0 is an eight-item scale that evaluates the severity of chronic pain, the presence of persistent pain due to pain days, and the degree of disability due to pain. It is easy, simple, useful and multidimensional. 80 volunteer participants who had chronic low back pain were studied.The data collection tools used in this study were; Clinic and Demographic Evaluation Form, Oswestry Low Back Pain Disability Index, Patterns of Activity Measure Pain, Roland-Morris Disability Questionnaire, Hospital Anxiety, and Depression Scale, and Graded Chronic Pain Scale 2.0. In this study, the forms were sent by e-mail. The Snowball sampling method was used in the data collection process.The stages of the Beaton Protocol were followed in the translation of the scale. Validity was evaluated with the Face, Content, and Construct validity analyses. Exploratory and confirmatory factor analyses were applied to determine the construct validity of the Turkish version of the scale. Reliability was evaluated with the test-retest method, the parallel forms method, and the internal consistency. Ten days after completing the scale, 30 participants filled out the scale again for the Test-retest method. One of the scales we used for the parallel forms method was RMDQ and the other was ODI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34755
        • Yeditepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult, Older Adult

Description

Inclusion Criteria:

Participants were Turkish speakers and volunteer participants aged 18 years and over and under 70 years of age who had recurrent or persistent chronic LBP for 6 months or more.The following participants with CLBP diagnosed by a physician were included in the study. These;

  • Disc herniations
  • Mechanical back pain
  • Lumbar strain
  • Spondylolisthesis
  • Degenerative disc disease
  • Muscle imbalance
  • Lumbago
  • A trigger point in the back muscles

Exclusion Criteria:

  • Having a history of illness such as Psychiatric disorder, Cognitive impairment, Dementia, or Alzheimer's
  • Low back pain that needs immediate treatment (neoplasm, cauda equina syndrome, infection, fracture)
  • Inflammatory low back pain
  • Low back pain due to a vascular cause

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
participants
The study included individuals whose native language is Turkish, who are over the age of 18 and under the age 70, diagnosed with chronic low back pain, without Psychiatric disorder, Cognitive impairment, Dementia, or Alzheimer's and who want to participate in the study.
Other: survey application

Data collection tools used in the study;

  • Clinic and Demographic Evaluation Form
  • Oswestry Low Back Pain Disability Index (ODI)
  • Patterns of Activity Measure Pain (POAM-P)
  • Roland-Morris Disability Questionnaire (RMDQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • Graded Chronic Pain Scale Version 2.0 (GCPS 2.0)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graded Chronic Pain Scale 2.0
Time Frame: 3 minutes
GCPS 2.0 measures multiple dimensions of pain in patients with chronic pain.
3 minutes
Clinic and Demographic Evaluation Form
Time Frame: 5 minutes
n the clinical section, there are questions the inclusion and exclusion criteria. According to this section, the patient is included in the study. In the demographic section, there is the section where the patient's demographic variables are collected.
5 minutes
Oswestry Low Back Pain Disability Index (ODI)
Time Frame: 5 minutes
ODI is a questionnaire measuring the effect of low back pain on daily life and the level of disability caused by this pain.
5 minutes
Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: 5 minutes
RMDQ is a sensitive tool that measures the loss of function and disability due to low back pain.
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 5 minutes
The hospital anxiety and depression scale have two sub-scales: Anxiety and Depression. 7 single-digit questions in the scale measure anxiety, while 7 questions with two numbers measure depression.
5 minutes
Patterns of Activity Measure Pain (POAM-P)
Time Frame: 15 minutes
Some established activity patterns reduce patients' quality of life with chronic pain, increase their pain, and limit their movement. These are modified patterns such as Overdoing, Avoidance, Pacing. POAM-P determines which of these patterns chronic pain patients use. There are 10 questions in each subsection, also 30 questions in total.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yeditepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 123456789 (Bandirma Onyedi Eylul University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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